Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

NCT ID: NCT01508286

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.

Detailed Description

This is a multicenter, multinational, open-label, non-comparative early access program designed to provide telaprevir to patients infected with hepatitis C virus genotype 1, who have a documented diagnosis of liver fibrosis and compensated liver disease (Child Pugh Grade A), and are expected to benefit from telaprevir-based therapy. Patients will be excluded if they are eligible for enrollment into an ongoing clinical study of telaprevir. Enrollment of patients into this study will continue until telaprevir becomes available for reimbursement in the country in which a patient resides or until September 2013, whichever occurs first, unless otherwise indicated per local regulations. During the first 12 weeks of the study, all patients will receive telaprevir administered orally with food every 8 hours in combination with peginterferon-alfa/ribavirin [PEG-IFN-alfa/RBV]). Patients will then be treated with Peg-IFN-alfa/RBV alone for an additional 12 or 36 weeks, based on how they respond to treatment (assessed by levels of hepatitis C viral RNA in the plasma, which reflects the number of virus particles in the bloodstream) and/or by type of patient (patients with severe fibrosis who had not received prior treatment or had previously relapsed during treatment, patients with prior partial or null response [who had only partially or had not responded to previous treatment], patients who had viral breakthrough [recurrence of viral copies during antiviral treatment], or patients with cirrhosis). For all patients, rules will be applied to ensure that telaprevir or Peg-IFN-alfa/RBV are stopped if subjects have viral breakthrough or treatment failure. All patients should have a follow up visit (including measurement of hepatitis C viral RNA levels in the bloodstream) 24 weeks after the last administered dose of any treatment. Dose modifications of telaprevir are prohibited and once telaprevir treatment is discontinued it may not be reinitiated in this study.

Conditions

Hepatitis C

Interventions

Telaprevir + peginterferon alfa + ribavirin

During the first 12 weeks of the early access program, all eligible patients will receive telaprevir 750 mg every 8 hours in combination with peginterferon-alfa and ribavirin.

Intervention Type: DRUG

peginterferon alfa + ribavirin

Patients with severe fibrosis who are treatment naïve or prior treatment relapsers will subsequently be treated with peginterferon-alfa and ribavirin alone for either an additional 12 or 36 weeks.

Intervention Type: DRUG

peginterferon alfa + ribavirin

Previously treated patients with prior partial or null response, or who had viral breakthrough, with severe fibrosis and all subjects with cirrhosis will subsequently be treated with peginterferon-alfa and ribavirin alone for an additional 36 weeks.

Intervention Type: DRUG

Other Intervention Names

experimental; experimental; experimental

Eligibility Criteria

Inclusion Criteria

• have evidence of hepatitis C virus infection genotype 1 (by molecular assay); - have quantifiable plasma hepatitis C viral RNA levels; - have documented liver fibrosis as assessed by liver biopsy or a non-invasive test showing severe fibrosis or cirrhosis (for subjects with severe fibrosis, the diagnostic test should have been performed within the past 18 months); - have compensated liver disease (Child-Pugh Grade A clinical classification); - have access to hepatitis C treatment (peginterferon-alfa/ribavarin)

Exclusion Criteria

• eligible for enrollment into an ongoing clinical study of telaprevir; - infected or co-infected with hepatitis C virus of a genotype other than genotype 1 and/or co-infected with HIV; - contraindication to the administration of peginterferon-alfa or ribavarin, or medical history or laboratory values that preclude treatment with peginterferon-alfa or ribavarin according to the respective local prescribing information; - history of having previously received an investigational treatment with hepatitis C viral protease or polymerase inhibitors (a class of drugs like telaprevir); - signs or symptoms of hepatocellular carcinoma (tests for serum alpha-fetoprotein and ultrasonography should have been done a maximum of 4 months before screening to screen for hepetocellular carcinoma)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Adelaide, , Australia

Bedford, , Australia

Box Hill, , Australia

Camperdown, , Australia

Central Queensland M C, , Australia

Concord, , Australia

Darlinghurst, , Australia

Fitzroy, , Australia

Fremantle, , Australia

Greenslopes, , Australia

Heidelberg, , Australia

Herston, , Australia

Kingswood, , Australia

Kogarah, , Australia

Liverpool, , Australia

Melbourne, , Australia

New Lambton Heights, , Australia

Parkville, , Australia

Parkville - Vic, , Australia

Perth, , Australia

Sydney, , Australia

Woolloongabba, , Australia

Graz, , Austria

Innsbruck, , Austria

Linz, , Austria

Vienna, , Austria

Wels, , Austria

Antwerp, , Belgium

Bruges, , Belgium

Brussels, , Belgium

Edegem, , Belgium

Genk, , Belgium

Ghent, , Belgium

Laken (Brussel), , Belgium

Leuven, , Belgium

Liège, , Belgium

Pinheiros, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

Rio de Janeiro, , Brazil

São Paulo, , Brazil

Hradec Králové, , Czechia

Opava, , Czechia

Prague, , Czechia

Praha 4 N/A, , Czechia

Ústí nad Labem, , Czechia

Berlin, , Germany

Cologne, , Germany

Düsseldorf, , Germany

Essen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Hamburg, , Germany

Hanover, , Germany

Herne, , Germany

Leipzig, , Germany

München, , Germany

Münster, , Germany

Würzburg, , Germany

Alexandroupoli, , Greece

Athens, , Greece

Heraklion Crete, , Greece

Ioannina, , Greece

Larissa, , Greece

Pátrai, , Greece

Thessaloniki, , Greece

Thessalonikis, , Greece

Budapest, , Hungary

Debrecen, , Hungary

Gyula, , Hungary

Kaposvár, , Hungary

Pécs, , Hungary

Szeged, , Hungary

Székesfehérvár, , Hungary

Luxembourg, , Luxembourg

Auckland, , New Zealand

Christchurch, , New Zealand

Hamilton, , New Zealand

Bucharest, , Romania

Constanța, , Romania

Iași, , Romania

Ploieşti, , Romania

Timișoara, , Romania

Moscow, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Stavropol, , Russia

Tyumen, , Russia

Yekaterinburg, , Russia

Belgrade, , Serbia

Belgrade Serbia, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

A Coruña, , Spain

Alcorcón, , Spain

Alicante, , Spain

Almería, , Spain

Ávila, , Spain

Barakaldo, , Spain

Barcelona, , Spain

Córdoba, , Spain

Donostia / San Sebastian, , Spain

Girona, , Spain

Granada, , Spain

La Coruÿa N/A, , Spain

León, , Spain

Madrid, , Spain

Majadahonda (Madrid), , Spain

Málaga, , Spain

Oviedo, , Spain

Palma de Mallorca, , Spain

Pamplona, , Spain

Pontevedra, , Spain

Sabadell, , Spain

Santa Cruz de Tenerife, , Spain

Santander, , Spain

Seville, , Spain

Toledo, , Spain

Valencia, , Spain

Zaragoza, , Spain

Basel, , Switzerland

Basel Bs, , Switzerland

Bern, , Switzerland

Geneva, , Switzerland

Lausanne, , Switzerland

Lugano, , Switzerland

Sankt Gallen, , Switzerland

Zurich, , Switzerland

Countries

Australia; Austria; Belgium; Brazil; Czechia; Germany; Greece; Hungary; Luxembourg; New Zealand; Romania; Russia; Serbia; Spain; Switzerland

References

Lepida A, Colombo M, Fernandez I, Abdurakhmanov D, Ferreira PA, Strasser SI, Urbanek P, Mangia A, Calleja JL, Iraqi W, DeMasi R, Lonjon-Domanec I, Moreno C, Wedemeyer H. Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis. PLoS One. 2015 Sep 23;10(9):e0138503. doi: 10.1371/journal.pone.0138503. eCollection 2015.

Reference Type: DERIVED

PMID: 26398503 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2490&filename=CR017857_CSR.pdf

Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis

Other Identifiers

VX-950HEP3002

Identifier Type: OTHER

Identifier Source: secondary_id

2010-023669-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017857

Identifier Type: -

Identifier Source: org_study_id